Trial Outcomes & Findings for Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome (NCT NCT02796092)

Last Updated: 2017-03-29

Results Overview

Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9). VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

12 months

Results posted on

2017-03-29

Participant Flow

Patients were recruited based on physician referral in a single specialized center between January 2014 and January 2015. The 1 year follow-up period was finished in February 2016.

Participant milestones

Participant milestones
Measure	Fibered Platinum Coils Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fibered Platinum Coils n=50 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs	Total n=100 Participants Total of all reporting groups
Age, Continuous	41.00 years STANDARD_DEVIATION 6.26 • n=99 Participants	44.34 years STANDARD_DEVIATION 8.45 • n=107 Participants	42.67 years STANDARD_DEVIATION 7.59 • n=206 Participants
Sex: Female, Male Female	50 Participants n=99 Participants	50 Participants n=107 Participants	100 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Living children	1.86 Children STANDARD_DEVIATION 0.96 • n=99 Participants	1.78 Children STANDARD_DEVIATION 0.71 • n=107 Participants	1.82 Children STANDARD_DEVIATION 0.8 • n=206 Participants
Pre-treatment Visual Analogue Score	7.14 units on a scale STANDARD_DEVIATION 1.55 • n=99 Participants	7.88 units on a scale STANDARD_DEVIATION 1.01 • n=107 Participants	7.51 units on a scale STANDARD_DEVIATION 1.36 • n=206 Participants
Pain in orthostatic position YES	48 participants n=99 Participants	50 participants n=107 Participants	98 participants n=206 Participants
Pain in orthostatic position NO	2 participants n=99 Participants	0 participants n=107 Participants	2 participants n=206 Participants
Pain in supine position YES	7 participants n=99 Participants	6 participants n=107 Participants	13 participants n=206 Participants
Pain in supine position NO	43 participants n=99 Participants	44 participants n=107 Participants	87 participants n=206 Participants
Dyspareunia YES	27 participants n=99 Participants	27 participants n=107 Participants	54 participants n=206 Participants
Dyspareunia NO	23 participants n=99 Participants	23 participants n=107 Participants	46 participants n=206 Participants
Dysmenorrhea YES	27 participants n=99 Participants	35 participants n=107 Participants	62 participants n=206 Participants
Dysmenorrhea NO	23 participants n=99 Participants	15 participants n=107 Participants	38 participants n=206 Participants
Urinary urgency YES	7 participants n=99 Participants	6 participants n=107 Participants	13 participants n=206 Participants
Urinary urgency NO	43 participants n=99 Participants	44 participants n=107 Participants	87 participants n=206 Participants
History of ovarian cystic disease YES	22 participants n=99 Participants	21 participants n=107 Participants	43 participants n=206 Participants
History of ovarian cystic disease NO	28 participants n=99 Participants	29 participants n=107 Participants	57 participants n=206 Participants
History of vaginal varicosities YES	10 participants n=99 Participants	8 participants n=107 Participants	18 participants n=206 Participants
History of vaginal varicosities NO	40 participants n=99 Participants	42 participants n=107 Participants	82 participants n=206 Participants
History of vulvar varicosities YES	18 participants n=99 Participants	19 participants n=107 Participants	37 participants n=206 Participants
History of vulvar varicosities NO	32 participants n=99 Participants	31 participants n=107 Participants	63 participants n=206 Participants
History of lower limb varices YES	45 participants n=99 Participants	44 participants n=107 Participants	89 participants n=206 Participants
History of lower limb varices NO	5 participants n=99 Participants	6 participants n=107 Participants	11 participants n=206 Participants
History of lower limb varices surgery YES	10 participants n=99 Participants	10 participants n=107 Participants	20 participants n=206 Participants
History of lower limb varices surgery NO	40 participants n=99 Participants	40 participants n=107 Participants	80 participants n=206 Participants
Maximum right pelvic venous caliber	7.38 mm STANDARD_DEVIATION 1.19 • n=99 Participants	7.36 mm STANDARD_DEVIATION 1.22 • n=107 Participants	7.37 mm STANDARD_DEVIATION 1.20 • n=206 Participants
Maximum left pelvic venous caliber	6.78 mm STANDARD_DEVIATION 1.96 • n=99 Participants	6.66 mm STANDARD_DEVIATION 1.55 • n=107 Participants	6.72 mm STANDARD_DEVIATION 1.76 • n=206 Participants
Varicocele YES	41 participants n=99 Participants	45 participants n=107 Participants	86 participants n=206 Participants
Varicocele NO	9 participants n=99 Participants	5 participants n=107 Participants	14 participants n=206 Participants
Ovarian vein reflux YES	40 participants n=99 Participants	35 participants n=107 Participants	75 participants n=206 Participants
Ovarian vein reflux NO	10 participants n=99 Participants	15 participants n=107 Participants	25 participants n=206 Participants
Waveform change in Valsalva's maneuver YES	25 participants n=99 Participants	30 participants n=107 Participants	55 participants n=206 Participants
Waveform change in Valsalva's maneuver NO	25 participants n=99 Participants	20 participants n=107 Participants	45 participants n=206 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Population presenting pre-treatment pain (more than 1 in VAS)

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=49 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Change in Pain Scale IMPROVEMENT	47 participants	48 participants
Change in Pain Scale NO IMPROVEMENT	2 participants	2 participants

SECONDARY outcome

Timeframe: 12 months

Population: Population presenting pre-treatment dyspareunia

Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=27 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=27 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Improvement of Dyspareunia IMPROVEMENT	24 participants	21 participants
Improvement of Dyspareunia NO IMPROVEMENT	3 participants	6 participants

SECONDARY outcome

Timeframe: 12 months

Population: Population presenting pre-treatment urinary urgency

Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=7 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=6 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Improvement of Urinary Urgency IMPROVEMENT	6 participants	6 participants
Improvement of Urinary Urgency NO IMPROVEMENT	1 participants	0 participants

SECONDARY outcome

Timeframe: 12 months

Population: Population presenting pre-treatment dysmenorrhea

Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=27 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=35 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Improvement of Dysmenorrhea IMPROVEMENT	24 participants	31 participants
Improvement of Dysmenorrhea NO IMPROVEMENT	3 participants	4 participants

SECONDARY outcome

Timeframe: 12 months

Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9). Patients answered just one question. Are you satisfied with the procedure? Being 0 = Completely unsatisfied, I regret having undergone a embolization procedure 9=Totally satisfied with the procedure, everything was perfect, I would recommend it to anyone with the same problem.

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=50 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Satisfaction With the Procedure	8.22 units on a scale Standard Deviation 1.04	7.90 units on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: intraoperative

Number of coils and number of vascular plugs used in each procedure

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=50 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Number of Devices Used	18.16 devices Standard Deviation 1.33	4.06 devices Standard Deviation 0.31

SECONDARY outcome

Timeframe: Intraoperative

Cost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay.

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=50 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Cost of Treatment	3295.05 US Dollars Standard Deviation 240.08	4069.79 US Dollars Standard Deviation 138.64

SECONDARY outcome

Timeframe: Intraoperative

Total time length of the procedure, from puncture to compression (in minutes)

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=50 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Total Intervention Duration	44.46 minutes Standard Deviation 4.09	29.02 minutes Standard Deviation 5.95

SECONDARY outcome

Timeframe: Intraoperative

Total fluoroscopy time, recorded by the equipment (in minutes)

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=50 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Fluoroscopy Time	33.41 minutes Standard Deviation 4.68	19.52 minutes Standard Deviation 6.14

SECONDARY outcome

Timeframe: Intraoperative

DAP, dose area product of the intervention, (in mGy\*cm\^2), recorded by fluoroscopy equipment

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=50 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Procedure Radiation Dose (DAP)	354573.00 mGy*cm^2 Standard Deviation 105047.76	189935.60 mGy*cm^2 Standard Deviation 180002.93

SECONDARY outcome

Timeframe: Intraoperative

AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=50 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Procedure Radiation Dose (AK)	947.99 mGy Standard Deviation 248.45	320.66 mGy Standard Deviation 134.33

SECONDARY outcome

Timeframe: intraoperative

Total number of events during the procedure

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=50 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Complications	11 minor events	4 minor events

SECONDARY outcome

Timeframe: 12 months

Toral number of events related to the procedure in the follow-up (1 year)

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=50 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Complications	0 events	0 events

SECONDARY outcome

Timeframe: 12 months

Scheduled re-embolization due to incomplete occlusion

Outcome measures

Outcome measures
Measure	Fibered Platinum Coils n=50 Participants Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 Participants Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Need for Re-embolization Re-embolized	7 participants	2 participants
Need for Re-embolization No	43 participants	48 participants

Adverse Events

Fibered Platinum Coils

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Vascular Plugs

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fibered Platinum Coils n=50 participants at risk Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark) Fibered platinum coils	Vascular Plugs n=50 participants at risk Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA) Vascular plugs
Vascular disorders Migration of implant or internal device	6.0% 3/50 • Number of events 3 • Intraoperative, 3, 6, and 12 months	2.0% 1/50 • Number of events 1 • Intraoperative, 3, 6, and 12 months
Musculoskeletal and connective tissue disorders Hematoma of neck	4.0% 2/50 • Number of events 2 • Intraoperative, 3, 6, and 12 months	4.0% 2/50 • Number of events 2 • Intraoperative, 3, 6, and 12 months
Vascular disorders Extravasation of blood	12.0% 6/50 • Number of events 6 • Intraoperative, 3, 6, and 12 months	4.0% 2/50 • Number of events 2 • Intraoperative, 3, 6, and 12 months

Additional Information

Prof. Alicia Laborda

GITMI (University of Zaragoza)

Phone: 0034 976 76 15 49

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place